Last August 15, the Food and Drug Administration (FDA) released a memorandum about the illegal manufacture, sale, and distribution unregistered medical-grade oxygen. The medical-grade oxygen are available in the country contained in cylindrical tanks that are prepared from chemical synthesis from raw materials, or from air separation machines. Their primary purpose is to provide pure and safe oxygen to the patients who can’t currently breathe normally under some circumstances like post-surgery
But recently, the FDA received reports about the existence of oxygen-generating machines being set-up by both public and private hospitals so that they could privately produce and give their own medical-grade oxygen to their patients – without being registered to the FDA. Product Registration is essential. When medical products are not registered to the FDA, it means that the products used did not undergo quality assurance/control, thus, safety, efficacy and quality may be compromised. Another one is that, delicate products like these medical-grade oxygen in tanks should be only manufactured in a manufacturing production scale level so that we could be sure that each process and raw materials are pure and safe.
These products are not just used for simple treatments but also for chronic or long-term ones. The patients who need clean and reliable oxygen supply will have their health compromised because the medical-grade oxygen given to them haven’t undergone the careful and sure inspection of the FDA that ensures every patient, and medical partner to elicit the best therapeutic outcome one medical practitioner may give.
In the memorandum published by the FDA, it said that in consistent mandates provided to FDA by Republic Act 9711 (Food and Drug Administration Act of 2009) and Republic Act 3720 (Food, Drug, And Cosmetic Act) as amended, the FDA hereby reiterates that establishments, including hospitals, involved in the manufacture, sale, offer for sale, and distribution of all drug products, including medical-grade oxygen are required to be licensed with FDA. Furthermore, all drug products are required to be registered before they can be manufactured, distributed, and sold.
Everyone deserves to be treated well and right. Maybe this is the right time to call the attention of those responsible for some of the illegal processes that are currently taking place in the medical field. The FDA is discouraging the public to buy/use products that are not FDA-approved. Be vigilant in using these kinds of products. If in doubt, contact FDA for any concerns.
Triple I Consulting guides companies in the licensing, and in preparing the legal requirements to ensure the safety and smooth registration of your product. Our Regulatory Affairs Department is able to provide proper assistance in the preparation of documents to minimize certain incomplete requirements for regulatory approvals and to avoid rejection of registration or licensing.